A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of BxC-I17e Administered Subcutaneously in Patients With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06055361
• Other study ID #: BRE-AD01-001
• Status: Recruiting
• Phase: Phase 1
• Start date: April 18, 2023
• Est. completion date: September 3, 2024

Study information

• Verified date: September 2023
• Source: Brexogen Inc.
• Contact: Hugh Lee
• Phone: 1-301-540-2600
• Email: hughlee[@]kcrnresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of a single SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: September 3, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients (males or females) aged 18 years or older.

2. Patients have documented history of moderate to severe AD, that has been present for at least 1 year

3. History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD

4. Patients must agree to apply stable doses of additive-free, basic bland emollient lotions twice daily for at least 7 days before the Baseline Visit.

5. Willingness and ability to comply with clinic visits and study-related procedures.

6. Patients should be able to read, understand, and be willing to sign the ICF

Exclusion Criteria:

1. Presence of any of the following laboratory abnormalities

• Hemoglobin < 11 g/dL
• WBC < 3.5 × 103/µL
• Platelet count < 125 × 103/µL
• Neutrophils < 1.75 × 103/µL
• AST/ALT > 1.5 × ULN
• Total bilirubin > ULN
• Creatinine > ULN
• Creatine phosphokinase > ULN

2. Positive test for hepatitis B surface antigen, and/or hepatitis C antibody

3. Active dermatologic conditions that may confound the diagnosis of AD

4. Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study

5. Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the patient's participation in this study

6. Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit.

7. Known history of human immunodeficiency virus (HIV) infection

8. Pregnant or breastfeeding women

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• BxC-I17e
Pharmaceutical form : solution for injection
• Placebo
Pharmaceutical form : solution for injection

Locations

Country	Name	City	State
United States	DermDox Centers for Dermatology	Camp Hill	Pennsylvania
United States	Arkansas Research Trials	North Little Rock	Arkansas
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Brexogen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs)	Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0	Baseline to Week 26
Secondary	Incidence, severity and relationship of adverse events(AEs)	Incidence, severity and relationship of adverse events as assessed by CTCAE v5.0	Baseline to Week 26
Secondary	Number of abnormalities and change from baseline in Vital signs	Supine blood pressure and pulse rate, tympanic temperature, and respiratory rate	Baseline to Week 26
Secondary	Number of abnormalities in 12-lead electrocardiogram (ECG)	PR interval, QRS interval, RR interval, QT interval and QT interval using Friderica's correction (QTcF)	Baseline to Week 26
Secondary	Number of abnormalities in clinical laboratory parameter	Hematology, clinical chemistry, and urinalysis parameters	Baseline to Week 26
Secondary	Frequency and proportion of clinically significant finding of physical examination	Assessments of the following body categories : skin, HEENT (head, eye, ears, nose, and throat), cardiovascular, respiratory, gastrointestinal, endocrine/metabolic, genitourinary, psychiatric, hematologic/lymphatics, musculoskeletal, neurologic, hepatic, and allergic/immunologic	Baseline to Week 26
Secondary	Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1	The IGA is an assessment instrument used in clinical studies to rate the severity of Atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).	Baseline to Week 8
Secondary	Change and percent change in Body Surface Area (BSA)	The BSA affected by atopic dermatitis will be assessed for each major section of the body (head, trunk, arms, and legs). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).	Baseline to Week 8
Secondary	Change and percent change in Eczema Area and Severity Index (EASI)	The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.	Baseline to Week 8
Secondary	Change and percent change in Scoring Atopic Dermatitis (SCORAD)	The SCORAD is a clinical tool for assessing the severity of Atopic Dermatitis. Total score ranged from 0 (absent disease) to 103 (severe disease).	Baseline to Week 8
Secondary	Change and percent change in Pruritus Numerical Rating Scale (NRS)	The Pruritus NRS is a simple assessment tool used to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the' worst itch imaginable'	Baseline to Week 8
Secondary	Change and percent change in Dermatology Life Quality Index (DLQI)	The DLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life	Baseline to Week 8
Secondary	Change and percent change in Patient-Oriented Eczema Measure (POEM)	The POEM is a validated 7-item questionnaire used to assess disease symptoms with a scoring system of 1 to 28. The higher score, the higher morbidity	Baseline to Week 8